Section Form and MSC
CTIS contains two sections (Form, MSC) that must be completed for an initial application.
Initial application details
- Cover letter: Placeholder to upload cover letter;
- Proof of payment of fee: In the Netherlands no proof of payment of fee has to submitted. However, you must upload the invoice details here;
- Compliance with Regulation (EU) 2016/679: Placeholder to upload statement;
- Deferral publication date: Trial category 1,2 or 3 has to selected for the publication date of trial information, including a justification for the selected category (see transparency rules). Deferral of publication date is possible by indicating a new publication date.
- Overview of the member states concerned including the proposed reporting member state. Also an overview of the participating countries outside the European Economic Area.